Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment (CEPELA)
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment|
- capability of the PillCam ESO 2 capsule endoscope to identify esophageal injury due to RFA therapy for atrial fibrillation [ Time Frame: 24-48 hrs post RFA, and 14 days post-RFA ] [ Designated as safety issue: Yes ]
- compare patient post-ablation symptoms to esophageal injury findings identified by PillCam ESO capsule endoscope [ Time Frame: 24-48 hrs post-RFA and 14 days post-RFA ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Single arm - all patients receive capsule endoscopy before and after RFA procedure.
Device: PillCam ESO Capsule Endoscope
Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Milan Dodig, MD||The Cleveland Clinic|